SYLLABUS - AAGL 6... · 2020-01-30 · ILEO-LUMBAR SPACE. Ceccaroni M., 2016 Ceccaroni M., 2011 (Right side-wall) (Leftt side-wall) Study design. Prospective case-series Single-centre

Be a Surgical “Multiplier” in MIGS Inspire Brilliance Through Teamwork

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Scientific Program ChairJubilee Brown, MD

Honorary ChairBarbara S. Levy, MD

PresidentMarie Fidela R. Paraiso, MD

SYLLABUSPLENARY 6: Endometriosis

Professional Education Information

Target Audience This educational activity is developed to meet the needs of surgical gynecologists in practice and in training, as well as other healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Disclosure of Relevant Financial Relationships As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME. Anti-Harassment Statement AAGL encourages its members to interact with each other for the purposes of professional development and scholarly interchange so that all members may learn, network, and enjoy the company of colleagues in a professional atmosphere. Consequently, it is the policy of the AAGL to provide an environment free from all forms of discrimination, harassment, and retaliation to its members and guests at all regional educational meetings or courses, the annual global congress (i.e. annual meeting), and AAGL-hosted social events (AAGL sponsored activities). Every individual associated with the AAGL has a duty to maintain this environment free of harassment and intimidation. AAGL encourages reporting all perceived incidents of harassment, discrimination, or retaliation. Any individual covered by this policy who believes that he or she has been subjected to such an inappropriate incident has two (2) options for reporting:

1. By toll free phone to AAGL’s confidential 3rd party hotline: (833) 995-AAGL (2245) during the AAGL Annual or Regional Meetings.

2. By email or phone to: The Executive Director, Linda Michels, at [email protected] or (714) 503-6200.

All persons who witness potential harassment, discrimination, or other harmful behavior during AAGL sponsored activities may report the incident and be proactive in helping to mitigate or avoid that harm and to alert appropriate authorities if someone is in imminent physical danger. For more information or to view the policy please go to: https://www.aagl.org/wp-content/uploads/2018/02/AAGL-Anti-Harassment-Policy.pdf

https://www.aagl.org/wp-content/uploads/2018/02/AAGL-Anti-Harassment-Policy.pdf

Table of Contents Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Exosomal Long Noncoding RNA-NONHAT076754 Faciliates Endometriosis Invasion and Predicts Endometriosis Recurrence J. Qiu .............................................................................................................................................................. 3 Laparoscopic Neurolysis for Deep Endometriosis with Somatic Nerves Involvement: A Prospective Cohort Study on 402 Patients Treated in a Third-Level Referral Center R. Clarizia ....................................................................................................................................................... 6 Outcomes in Women Undergoing Conservative Compared to Definitive Surgery for Chronic Pelvic Pain: A Prospective Cohort C. Lee ........................................................................................................................................................... 10 Deep Endometriosis of the Bowel: A Surgical Approach C.R. Zhu ....................................................................................................................................................... 12 How We Do It: Identification and Dissection of the Sacrospinous Ligament and Lumbosacral Spinal Root on a Patient with Endometriosis of the Pelvic Floor C.A. Souza ................................................................................................................................................. …13 Post-operative Dienogest Following Conservative Endometriosis Surgery: A Systematic Review and Meta-Analysis A. Zakhari .................................................................................................................................................... 14 Cultural and Linguistics Competency ......................................................................................................... 16

Plenary 6: Endometriosis

Moderator: Alberto Mattei, Anurita Singh

Description This session presents several high-quality studies concerning the management of endometriosis. The latest innovation in both medical and surgical therapeutic options of this complex disease will be discussed.

Objectives Learning Objectives: At the conclusion of this activity, the participant will be able to: 1) Discuss current data concerning different management options for endometriosis; 2) identify different characteristics of patients diagnosed with endometriosis; and 3) discuss the latest medical protocols and surgical techniques for the management of patients with endometriosis.

2:00 Exosomal Long Noncoding RNA-NONHAT076754 Faciliates Endometriosis Invasion and Predicts Endometriosis Recurrence Discussant: A.C. Balica

J. Qiu

2:10 Laparoscopic Neurolysis for Deep Endometriosis with Somatic Nerves Involvement: A Prospective Cohort Study on 402 Patients Treated in a Third-Level Referral Center Discussant: A. Satkunaratnam

R. Clarizia

2:20 Outcomes in Women Undergoing Conservative Compared to Definitive Surgery for Chronic Pelvic Pain: A Prospective Cohort Discussant: J.K. Moulder

C. Lee

2:30 Deep Endometriosis of the Bowel: A Surgical Approach Discussant: N. Fogelson

C.R. Zhu

2:40 How We Do It: Identification and Dissection of the Sacrospinous Ligament and Lumbosacral Spinal Root on a Patient with Endometriosis of the Pelvic Floor Discussant: J.L. Salgado

C.A. Souza

2:50 Post-operative Dienogest Following Conservative Endometriosis Surgery: A Systematic Review and Meta-Analysis Discussant: E. Dun

A. Zakhari

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PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Director, AAGL* Linda D. Bradley, Medical Director, AAGL* Erin T. Carey Consultant: MedIQ Mark W. Dassel Contracted Research: Myovant Sciences Erica Dun* Adi Katz* Linda Michels, Executive Director, AAGL* Erinn M. Myers Speakers Bureau: Laborie Medical Technologies, Teleflex Medical Other: Unrestricted educational grant to support NC FPMRS Fellow Cadaver Lab: Boston Scientific Corp. Inc. Amy Park* Grace Phan, Professional Education Specialist, AAGL* Harold Y. Wu* Linda C. Yang Other: Ownership Interest: KLAAS LLC SCIENTIFIC PROGRAM COMMITTEE Linda D. Bradley, Medical Director, AAGL* Jubilee Brown* Nichole Mahnert* Shanti Indira Mohling* Fariba Mohtashami Consultant: Hologic Marie Fidela R. Paraiso* Shailesh P. Puntambekar* Matthew T. Siedhoff Consultant: Applied Medical, Caldera Medical, CooperSurgical, Olympus Amanda C. Yunker Consultant: Olympus Linda Michels, Executive Director, AAGL*

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Adrian C. Balica* Roberto Clarizia* Erica Dun* Nicholas Fogelson* Caroline Lee* Alberto Mattei* Janelle K. Moulder Consultant: Hologic Junjun Qiu* Juan L. Salgado Speakers Bureau: Medtronic Abheha Satkunaratnam Consultant: AbbVie, Allergan Pharmaceutical, Bovie Medical, Hologic Anurita Singh* Charles A. Souza* Andrew Zakhari* Cici R. Zhu* Content Reviewer has nothing to disclose. Asterisk (*) denotes no financial relationships to disclose.

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Laparoscopic Neurolysis for Deep Endometriosis with Somatic Nerves Involvement: A Prospective Cohort Study on 402 Patients

Treated in a Third-Level Referral Center

Roberto Clarizia MD, PhD,

Department of Obstetrics and Gynecology, Gynecologic Oncology and Minimally-Invasive Pelvic Surgery,

International School of Surgical Anatomy, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona – ItalyChief: Marcello Ceccaroni, M.D.,

Ph.D.

Roberto Clarizia, M.D., Ph.D.

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Disclosure• I have no financial relationships to disclose

Objective

• Discuss the diagnosis and treatment of endometriosis and somatic nerves

Endometriosis and somatic nerves

• Endometriotic or fibrotic involvement of somatic nerves,sacral plexus and sacral roots are very common causes ofpelvic and ano-genital pain (39%)Nehme-Schuster et al., Lancet 2005; Possover et al., Fertil Steril 2007

• When endometriosis develops as parametrial diseaseextending to the pelvic wall, a frequent involvement ofsomatic nerves is found

•Possover et al., J Urol 2009, Ceccaroni et al., Surg Rad Anat 2010

(ISSA School, 2010)

• Often difficult differential diagnosis• Patients observed after years of disease’s progression without a

precise diagnosis• “Pilgrimage” between orthopaedics, neurosurgeons and

gynaecologists• Often resistant pain, not healed by NSAIDs (FANS) or opioids

Robert et al., Eur Urol 2005; Possover et al., Min Invas Neurosurg 2007;

Ceccaroni, Clarizia et al., Surg Rad Anat 2010,

Ceccaroni, Clarizia et al., J Spin Disorders 2011,

Ceccaroni, Clarizia et al., Eur J Obst Gyn 2011

DiagnosisDi iEndometriosis and somatic nerves

(ISSA School, 2010)

Endometriosis and somatic nerves: treatment

• Surgical decompression/neurolysis revealed to be effective in pain relief, comparable to neuromodulationRobert et al., Eur Urol 2005; Possover et al., Min Invas Neurosurg 2007; Ceccaroni, Clarizia et al., Surg Rad Anat 2010, Ceccaroni, Clarizia et al., J Spin Disorders 2011, Ceccaroni, Clarizia et al., Eur J Obst Gyn 2011

• Trans-perineal approach• Trans-gluteal approach• “Open” approach• Laparoscopic approach• Laparoscopic Neuro Navigation (LANN)• Sacral neuromodulation

T i l h

Different surgical approaches forsomatic nerves Endometriosis:

Abdominal approach Laparoscopic approach

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LaparoscopicSurgical Approaches

Decompression Neurolysis

Parietal Pelvic Fascia

Nerve

Nerve

Nodule Nodule

NoduleNodule

(Ceccaroni M, et al 2006)


Medial Approach

PARARECTAL AND RETRORECTAL SPACES

LaparoscopicSurgical Approaches

Lateral approach

ILEO-LUMBAR SPACE

Ceccaroni M., 2016 Ceccaroni M., 2011

(Right side-wall)(Leftt side-wall)

Study design

Prospective case-series Single-centreSingle-surgeon study on 402 patients8 years period

Laparoscopic neurolysis for deep endometriosis infiltrating pelvic wall and somatic nerves:

a prospective cohort study on 382 patients M Ceccaroni et al

Median follow up = 44,3 months (range 18-84)

(Ceccaroni M, et al 2006)

(Right side-wall)

Material and Methods382 patients with deep infiltrating endometriosis complaining of recurrent cyclic sciatica, pudendalgia and ano-genital paintreated by laparoscopic eradication of DIE with decompression/neurolysis of sacral roots and somatic nervestwo different laparoscopic transperitoneal approaches were feasible to get access to the lateral pelvic wall in case of:



(A) deep pelvic endometriosis with rectal and/or parametrial

involvement extending to pelvic wall and caudal somatic nerves (Sacral Plexus, S2-S4, Pudendal nerve)

MEDIAL APPROACH

(B) isolated endometriosis of pelvic wall and cranial

somatic nerves(Obturator nerve, Lumbo-sacral trunk,

S1, Sciatic nerve)LATERAL APPROACH

All the procedures were performed by a gynecologic pelvic surgeon skilled in neuroanatomy (M.C.)

Distribution of lesions



Results

Depending from the grade of infiltration, either decompression (resection of disease up to the parietal fascia covering the nerve) or neurolysis (resection of disease together with the affected fascia covering the nerve and with perinevral planes and nevral fibers) was performed



(Ceccaroni M, et al. Surg Rad Anat, 2010)

(Right side-wall)

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Concomitant procedures: bowel resection



Pathology



Endometriosis

Fibrosis

Endometriosis + Fibrosis

ResultsComplete relief from neurologic symptoms was achieved in all patients at 6 months after surgerysurgery



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Sciatica

Pudendal pain

Median VAS score

Post-operative complications

Post-operative Neuritis was reported in 77 patients (20.1%) and successfully treated with corticosteroids and pregabalin



y p

3 Months1 Month

6 Months

Conclusions



Nerve-Sparing procedures successfully treat the disease with an adequate radicality, offering good results in terms of pain relief and neurological bladder/bowel and sexual dysfunctions, with morbidity reductions and Quality of Life improvement

Anatomical knowledge is a key for a better know-how and for a safe endoscopic surgery, minimizing the risks of neurological complications

Laparoscopic approach for neurolysis/decompression of somatic nerves affected by DIE extending to the pelvic wall, is the less invasive and the more accurate and effective treatment offering pain relief, recovery of motoric impaired functions and complete eradication of the disease

Involvement of somatic nerves in DIE is not an uncommon condition, undiagnosed or misdiagnosed in the majority of cases

Gynecologist is supposed to be the most indicated and expert specialist do diagnose/treat this condition and to offer the adequate care to these “orphan” patients

Considering that this kind of surgery requires uncommon surgical skills and anatomical knowledge, it should be performed only in selected Referral Centres

Thank you!

Page 8

Conclusions

Pelvic wall spread of deep infiltrating endometriosis is often underdiagnosed and might be more usual than thought

Laparoscopic retroperitoneal nerve-sparing approach to endometriosis extending to the pelvic wall, with somatic nerve neurolysis and decompression proved to be a minimally-invasive, feasible and safe procedure, in expert hands

The procedure revealed to be effective in pain relief, recovery of impaired neurological functions and neuromotoric impairment of the pelvic floor and the leg related to endometriosis

It should be limited to referral laparoscopic centres led by neuro-anatomy skilled surgeons



Acknowledgements

• Giovanni Roviglione MD1, Maria Manzone MD1, Daniele Mautone MD1, Francesco Bruni MD1, Anna Stepniewska MD1, Matteo Ceccarello1 MD, Marcello Ceccaroni MD, PhD1.

• Department of Obstetrics and Gynecology, Gynecologic Oncology and Minimally-Invasive Pelvic Surgery,

• International School of Surgical Anatomy, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona – ItalyChief: Marcello Ceccaroni, M.D., Ph.D.

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OUTCOMES IN WOMEN UNDERGOING CONSERVATIVE COMPARED TO DEFINITIVE

SURGERY FOR CHRONIC PELVIC PAIN: A PROSPECTIVE COHORT

Caroline Lee, MDUniversity of British Columbia

Disclosure● I have no financial relationships to disclose

Objectives● Compare pelvic pain and quality-of-life outcomes in women undergoing

conservative vs. definitive surgery

Introduction● Surgical options1

○ Definitive surgery: hysterectomy and/or bilateral salpingo-oophorectomy

○ Conservative surgery: excision and/or cautery of endometriosis

● Evidence on surgery and pelvic pain ○ Surgery known to improve pain

symptoms1,2,3

○ However, there is a lack of surgical outcome studies that use quality of life questionnaires

○ The predictive factors for successful surgical outcomes are unknown

Methods● Prospective research cohort study

○ Patients presenting to our tertiary care centre for chronic pelvic pain and endometriosis ○ December 2013 to July 2016○ Evaluated via a baseline questionnaire, clinical evaluation, 1-year follow up questionnaire, and 2-year follow up

questionnaire

● Outcomes○ Primary outcomes

■ Chronic pelvic pain on a self-rated numerical rating scale (0-10)■ Endometriosis Health Profile-30 (0-100%)

○ Secondary outcomes ■ Pain subscales (0-10)■ Psychological measures

● Analysis○ SPSS 26.0 to perform Mann-Whitney U test, Chi-square test of homogeneity, and mixed-effect linear regression

Overview of ResultsConservative surgery Definitive surgery p-value

Number of patients 474 154

Follow up at 1 year 253 (53%) 63 (41%)

Follow up at 2 years 195 (41%) 57 (37%)

Average age 34 8 40 6 <0.001

BMI 25.2 5.5 27.0 6.4 0.001

Stage of endometriosis• Not endometriosis• Stage I-II• Stage III-IV

• 70 (15%)• 232 (49%)• 116 (24%)

• 26 (17%)• 76 (49%)• 28 (18%)

0.33

Oophorectomy• No or unilateral• Bilateral

• 458 (97%)• 16 (3%)

• 127 (82%)• 27 (18%)

<0.001

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Pain Outcomes Baseline 1 year 2 years p-value

Chronic pelvic pain• Conservative• Hysterectomy

• 7.0 0.1• 7.4 0.2

• 5.5 0.2• 5.1 0.4

• 5.6 0.2• 5.9 0.5

0.92(Time = 0.007)

Dysmenorrhea• Conservative• Hysterectomy

• 5.5 0.2• 6.6 0.3

• 4.0 0.2• 0.4 0.2

• 3.3 0.2• 0.2 0.2

<0.001(Time = 0.004)

Superficial dyspareunia• Conservative• Hysterectomy

• 3.8 0.2• 4.0 0.3

• 3.2 0.2• 3.1 0.4

• 3.4 0.2• 2.6 0.4

0.23(Time = 0.29)

Deep dyspareunia• Conservative• Hysterectomy

• 6.4 0.1• 6.5 0.3

• 4.4 0.2• 3.6 0.4

• 4.3 0.2• 3.0 0.4

0.005(Time = <0.001)

Dyschezia• Conservative• Hysterectomy

• 4.5 0.1• 4.9 0.2

• 3.1 0.2• 2.6 0.3

• 3.0 0.2• 2.6 0.3

0.09(Time = 0.005)

Quality of Life Outcomes

Baseline 1 year 2 years p-value

EHP-30• Conservative• Hysterectomy

• 53.1 1.1%• 56.5 1.6%

• 31.7 1.6%• 18.5 2.5%

• 33.3 1.8%• 20.0 3.1%

0.03(Time = <0.001)

GAD-7• Conservative• Hysterectomy

• 6.9 0.3• 7.0 0.5

• 5.3 0.3• 4.7 0.6

• 6.1 0.4• 5.3 0.6

0.36(Time = 0.12)

PHQ-9• Conservative• Hysterectomy

• 9.3 0.3• 10.1 0.6

• 6.8 0.4• 5.8 0.6

• 7.3 0.4• 5.4 0.6

0.60(Time = 0.002)

Pain catastrophizing• Conservative• Hysterectomy

• 21.5 0.7• 21.2 1.1

• 14.0 0.8• 8.9 1.2

• 13.9 0.8• 10.5 1.6

0.98(Time = <0.001)

Discussion● Primary outcomes

○ Both chronic pelvic pain and EHP-30 scores improved significantly with time○ However, there was a statistically significant improvement in EHP-30 scores in the

hysterectomy vs. conservative surgery group● Secondary outcomes

○ Dysmenorrhea, deep dyspareunia, and dyschezia improved with time ○ PHQ-9 and pain catastrophizing improved with time

● Conclusion ○ Both conservative and definitive surgery result in improvement in pain outcomes ○ However, quality of life is more significantly improved in the hysterectomy group ○ This may be attributable to lack of dysmenorrhea

Future Directions

● Further analysis of data ○ Impact of the following factors:

■ Stage of endometriosis ■ Positive histology vs. negative histology for endometriosis■ Hysterectomy in those < 40 years of age vs. > 40 years of age

○ Predictors of surgical success

Acknowledgments● Catherine Allaire, MD, University of British Columbia● Christina Williams MD, University of British Columbia● Mohamed Bedaiwy MD, PhD, University of British Columbia ● Paul Yong, MD, PhD, University of British Columbia

References1. Leyland, N., et al., Endometriosis: diagnosis and management, in J Obstet

Gynaecol Can. 2010: Canada. p. S1-32.2. Namnoum, A.B., et al., Incidence of symptom recurrence after hysterectomy

for endometriosis. Fertil Steril, 1995. 64(5): p. 898-902.3. Shakiba, K., et al., Surgical treatment of endometriosis: a 7-year follow-up on

the requirement for further surgery. Obstet Gynecol, 2008. 111(6): p. 1285-92.

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Deep Endometriosis of the Bowel: A Surgical Approach

Presenter: Cici Ruoxi Zhu, MD, FRCSC Obstetrics and Gynecology, The Ottawa Hospital

Ottawa, ON, Canada

Video Objective: The objectives of this video are to define bowel endometriosis and to explore various surgical parameters for the different types of surgical excision. Then, a specific surgical approach will be demonstrated. Setting: Our case is of a 34 year old nulliparous woman who presented for surgical management of deep endometriosis, as she was unable to tolerate medical management. She also presented with rectal bleeding and fecal urgency. This case was performed at a tertiary care setting hospital in Canada. Interventions: Surgical management of bowel endometriosis is indicated for symptom and pain relief, intolerance to medical management and to prevent complete obstruction. Importantly, operative planning and management should involve a multidisciplinary team involving gynecologists, general or colorectal surgeons and radiologists. When planning a surgical approach to deep endometriosis of the bowel, patient characteristics such as age and BMI, as well as their specific symptoms and level of pain, quality of life and fertility goals must be considered. As well, the actual lesion must be investigated with respect to size, number, location, depth of infiltration, and amount of intestinal wall circumference involved. Then, various surgical techniques can be performed depending on these specific characteristics, such as nodule shaving, nodular resection and segmental resection and re-anastomosis. For our surgical case, segmental resection and re-anastomosis was indicated after intra-operative colonoscopy showed significant luminal obstruction. The video demonstrates a blood vessel preservation and nerve sparing approach, highlighting blood supply, sympathetic and para-sympathetic innervation. Conclusion: The patient was discharged post-operative day 2 and reported complete resolution of symptoms at her clinical follow-up. This surgical video demonstrates and advocates a multidisciplinary approach to bowel endometriosis to improve patient quality of life.

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How We Do It: Identification and Dissection of the Sacrospinous Ligament and Lumbosacral Spinal Root on a Patient with Endometriosis of the Pelvic Floor

Presenter: Charles Arruda Souza, MD

School of Minimally Invasive Surgery, Instituto Crispi Rio de Janeiro, Brazil

Video Objective: Our aim is to rise awareness of pelvic floor endometriosis and describe a technique to dissect the pelvis until the pelvic floor muscles identifying the lumbosacral nerves and the main structures of the pelvis. Setting: A 23-year-old woman with cyclic pelvic pain since menarche had a history of claudication and pain in the right lower limb accompanied by dyschezia. At the vaginal and rectal examination, the patient had a nodule in the region of the right sacrospinous ligament, fixed in the pelvis and painful to palpation. The MRI showed a right posterolateral vaginal wall lesion on the uterosacral ligament and the anterior wall of the rectum, that touched the levator ani muscle infiltrating the sacrospinous ligament. Interventions: The medial dissection of the lesion was performed by developing the pararectal space, resecting the uterosacral ligaments, ureterolysis and identifying the hypogastric nerve. Then, during lateral dissection of the lesion, we identified the iliac vessels and the obturator nerve after pelvic lymphadenectomy. The lumbar trunk, the sacral root S1, the superior gluteal artery and the S2 and S3 roots were identified posteriorly. Thus, we identified the lesion extending from the paracolpus and the rectal wall to the sacrospinous ligament in contact with the levator ani muscle. With both sides dissected, it was possible to approach the lesion preserving noble structures such as the ureter, uterine artery and splanchnic nerves. Conclusion: Although endometriosis on the pelvic floor is a rare condition, deeply infiltrating endometriosis is more often diagnosed in young woman such as our patient. Surgical techniques must be developed to asses those type of lesions and videos like this are a form to discuss different approaches to the pelvic floor.

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POST-OPERATIVE DIENOGEST FOLLOWING CONSERVATIVE ENDOMETRIOSIS SURGERY:

Dr. Andrew Zakhari, FRCSCMount Sinai Hospital – University of Toronto

A SYSTEMATIC REVIEW AND META-ANALYSIS

Disclosure● I have no financial relationships to disclose

Objectives

● Summarize the current treatment paradigm of endometriosis

● Discuss the pharmacological profile of dienogest

● Review the literature on recurrence of endometriosis with post-operative suppression using dienogest

Endometriosis in the 21st Century

● Explosion of therapeutic options

● Improved expertise in managing fertility

↑ public awareness

earlier diagnosis

earlier medical

treatment

Net result: minimizing surgical exposure for patients

Dienogest● Unique synthetic progestogen¹,²

● Highly selective for progesterone receptor

● Central and peripheral action in treating endometriosis³

● Anti-androgenic, anti-estrogenic, anti-inflammatory, and anti-angiogenic

● Well tolerated What is the evidence for dienogest in post-operative suppression of conservatively treated endometriosis?

Systematic Literature Review

• Inclusion:• RCTs, observational studies• Pre-menopausal women• Conservative surgery• Post-operative treatment 6mo+

• Exclusion:• Post-menopausal• Bilateral oophorectomy• Non-therapeutic surgery• Recurrent disease

Page 14

361 results

19 full text

11 included

342 irrelevant

8 excluded• 3 wrong outcomes• 2 non-extractable• 2 wrong intervention• 1 wrong patient pop.

Results

Design

• 10 Retrospective cohort• 1 Prospective cohort

Patients

• 1314 Dienogest• 929 Controls (total: 2243)

Follow up

• Treatment: 6 – 79 months• Follow up 6 – 60 months

Results

● Recurrence

○ Patients receiving dienogest had a low rate of recurrence of endometriosis

3 cases per 100 women, 95% CI: 2.08 – 4.10 (11 studies, n = 1314)

● Versus Controls

○ Odds of recurrence were significantly lower in women receiving dienogest compared to no treatment

Log odds: -2.09, 95% CI: -2.59 – -1.59, p<0.001 (7 studies)

Final thoughts

● Endometriosis is a chronic condition

● Optimizing the balance between medical and surgical care is key

● Post-operative suppression works

Acknowledgments● Dr. Darl Edwards, FRCSC, Department of OBGYN, Mount Sinai Hospital –

University of Toronto

● Michelle Ryu, BSc, Mount Sinai Hospital

● Dr. Olga Bougie, FRCSC/MPH, Department of OBGYN, Queen’s University

● Dr. Ally Murji, FRCSC/MPH, Department of OBGYN, Mount Sinai Hospital –University of Toronto

References1. Paul L. McCormack, Dienogest: A review of its use in the treatment of

endometriosis, Drugs, 2010, Vol 70, 2073-20882. M. Oettel, H. Breitbarth, W. Elger, T. Gräser, D. Hübler, G. Kaufmann, C.

Moore, V. Patchev, W. Römer, J. Schröder, L. Sobek & H. Zimmermann, The pharmacological profile of dienogest, The European Journal of Contraception and Reproductive Healthcare, 2009, Vol 4, 2-13

3. Antonio Simone Laganà, Salvatore Giovanni Vitale, Roberta Granese, Vittorio Palmara, Helena Ban Frangež, Eda Vrtačnik-Bokal, Benito Chiofalo & Onofrio Triolo, Expert Opinion on Drug Metabolism & Toxicology, 2017, Vol 13, 593-596

Page 15

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

Page 16

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

Documents

SYLLABUS - AAGL 6... · 2020-01-30 · ILEO-LUMBAR SPACE. Ceccaroni M., 2016 Ceccaroni M., 2011 (Right side-wall) (Leftt side-wall) Study design. Prospective case-series Single-centre